Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0389-2022·Announced 2022-01-26

Physicians CARE Extra Strength Pain Reliever recalled for CGMP deviations

Medique Products is recalling Physicians CARE Extra Strength Pain Reliever tablets nationwide because they were not manufactured under Current Good Manufacturing Practices (CGMP), as determined by an FDA inspection.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing compliance deviation without evidence of actual product harm. This falls under the Moderate category for precautionary recalls related to manufacturing control issues.

Plain-English summary

Medique Products is recalling Physicians CARE Extra Strength Pain Reliever, a combination pain reliever containing acetaminophen (250 mg), aspirin (250 mg), and caffeine (65 mg). The product is sold in 100-count tablet cartons containing 50 packets of 2 tablets each, with UPC 0 73577 90316 6, manufactured for Acme United Corporation in Fairfield, Connecticut.

The recall was initiated after an FDA inspection identified that the product was not manufactured under Current Good Manufacturing Practices (CGMP). A total of 3,260,400 tablets across multiple lots with expiration dates ranging from October 2021 through May 2023 have been distributed nationwide in the USA.

Consumers who have purchased this product should stop using it. Affected lot and carton code numbers are listed in the FDA recall notice. Consumers with questions about the recall should contact the manufacturer or the FDA.

The recalled product

Product: Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577…
Manufacturer: Medique Products
Category: Drug — Pain Reliever / Over-the-Counter
Hazard: cgmp-deviation
manufacturing-control
Affected units: 3,260,400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lots: (Packet
Carton) 6151
4360 Exp. 10/2021
6240
4446 Exp. 12/2021
6331
4484 Exp. 02/2022
6413
4551 Exp. 04/2022
6699
4679 Exp. 10/2022
6751
4714 Exp. 12/2022
6855
4750 Exp. 01/2023
6868
4761 Exp. 02/2023
6899
4776 Exp. 02/2023
7061

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Medique Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Medique Products

See all →

Moderate
Medique Pain-Off Tablets Recalled for Manufacturing Practice Violations
FDA (Drugs) · 2022-01-26
Moderate
Extra Strength Headache tablets recalled for CGMP manufacturing deviations
FDA (Drugs) · 2022-01-26

Same hazard · cgmp deviation