FDA Drug Recalls

436 recalls, newest first

Class I · High risk Completed Jun 18, 2020

Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1460-2020

Class I · High risk Completed Jun 18, 2020

BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1459-2020

Class I · High risk Completed Jun 18, 2020

BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1458-2020

Class I · High risk Completed Jun 18, 2020

BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Berry Blast, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1457-2020

Class I · High risk Completed Jun 18, 2020

A Clean Choice CBD, Hemp Oil Extract Tincture, Sweet Mint, 500mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1456-2020

Class I · High risk Completed Jun 18, 2020

A Clean Choice CBD, Hemp Oil Extract Tincture, Strawberry Creme, 1000mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1455-2020

Class I · High risk Completed Jun 18, 2020

A Clean Choice CBD, Hemp Oil Extract Tincture, French Vanilla, 1000 mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1454-2020

Class I · High risk Completed Jun 18, 2020

Made by Hemp 1000MG Hemp Extract, Strawberry Creme, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76554 4

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1453-2020

Class I · High risk Completed Jun 18, 2020

Made by Hemp 1000MG Hemp Extract, Mojito Lime, 1 OZ (30 ML) bottles, Dist by: MHR Brandsl, Jenison, M,I UPC 8 02991 76552 0

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1452-2020

Class I · High risk Completed Jun 18, 2020

Made by Hemp 1000MG Hemp Extract, French Vanilla, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76553 7

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1451-2020

Class I · High risk Completed Jun 18, 2020

Tasty Drops Hemp Oil Extract, Vanilla, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1450-2020

Class I · High risk Completed Jun 18, 2020

Tasty Drops Hemp Oil Extract, Spearmint, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991…

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1449-2020

Class I · High risk Completed Jun 18, 2020

Tasty Drops Hemp Oil Extract, Berry, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76469 1

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1448-2020

Class I · High risk Completed Jun 18, 2020

Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305…

Reason Chemical Contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1447-2020

Class II · Moderate risk Completed May 27, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto…

Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels

Apotex Inc. NDC 60505-0260-1 D-1303-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. D-0185-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 63868-480-24 D-0184-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 0363-0131-30 D-0183-2020

Class II · Moderate risk Completed Oct 1, 2019

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 55111-404-34 D-0182-2020

Class II · Moderate risk Completed Oct 1, 2019

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 55111-131-60 D-0181-2020

Class II · Moderate risk Completed Oct 1, 2019

Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 55111-130-30 D-0180-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 11673-849-40 D-0179-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. D-0178-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison)…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 71713-203-02 D-0177-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 43598-808-62 D-0176-2020